NCT00138047

Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa

Randomized, Double-Blind, Placebo-Controlled Trial of Zinc Supplementation in HIV-1-Infected Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 6 Months – 60 Months
• Healthy volunteers: Not accepted

Summary

The goal of the study is to rule out a harmful effect of zinc supplementation in HIV-1-infected children. The null hypothesis is that zinc supplementation will increase plasma HIV RNA levels.

Detailed description

A randomized, double-blind, placebo-controlled equivalence trial of zinc supplementation was conducted at Grey's Hospital in Pietermaritzburg, South Africa. Ninety-six HIV-1-infected children were randomly assigned to receive 10 mg of elemental zinc as sulfate or placebo daily for 6 months. Baseline measurements of plasma HIV-1 viral load and the percentage of CD4+ T-lymphocytes were established at two study visits prior to randomization, and measurements were repeated 3, 6 and 9 months after starting supplementation. Plasma HIV-1 viral load and the percentage of CD4+ T-lymphocytes were compared before and after supplementation.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	zinc supplementation

Timeline

• Start date: 2003-03-01
• Completion: 2004-09-01
• First posted: 2005-08-30
• Last updated: 2005-12-05

Locations

1 site across 1 country: South Africa